Improving the Design of Medical Devices: A Dispatch from IDSA Medical 2018

Industry conferences, like the IDSA Medical Design Conference held last month in Boston, continue to be a great way to touch base with our colleagues across the industry and discuss what’s on our collective minds.

It was clear from the conference that the integration of research into medical product design is getting more rigorous. It hasn’t been that long since the FDA first began to expect evidence of usability validation of medical devices, and the way it’s being pursued continues to evolve. The depth and breadth of usability testing is expanding. Here are eight takeaways from our two days in Boston:

1: The focus on generative research continues to intensify.

Generative research was at the center of the two pre-conference workshops we attended the day before the conference. We’ve previously noted the influence of consumer design on medical, and this is one more area where that’s occurring. The growing appreciation for design thinking techniques in the consumer product space is rippling outward into medical.

2: There are significant obstacles to getting generative research off the ground in the medical world.

Medical product design research is a whole different animal from consumer and B2B product design research. And all of us who are doing this kind of work know this well!

Recurrent and pervasive challenges include recruitment, patient confidentiality, and gaining access to healthcare venues. We were excited to learn at the conference about Sean Hagen‘s work on the IDSA Patient Safety Task Force, which we’re looking to help designers access healthcare facilities for research purposes.

3: Once you’re in, it’s still challenging.

The first pre-conference workshop was great at highlighting the challenges of conducting research in medical environments. Once you get access, how do you plan and organize for contextual inquiry in a medical environment, especially someplace like an operating room?

It’s a significant balancing act between designers, researchers, the needs of our clients, the needs of facilities, and most importantly the needs of patients who are being served by the facility — and this workshop did a good job of communicating some best practices for how to organize oneself and collect info.

Once you get access, how do you plan and organize for contextual inquiry in a medical environment?

We came away with tips for what you might want to carry while limited to the two pockets in standard-issue scrubs; the valuable advice to ensure you assign someone to keep your camera tripod stable; a reminder to keep your focus on the areas you’re studying; and ways to prepare for cold rooms and long hours without food.

4: But the case for generative research might be strongest in medical product design.

One speaker said, “We’re all in the alignment business,” meaning our work is to get stakeholders, patients, and engineers aligned in how to design medical products that deliver safe and effective therapy, while meeting all stakeholder needs. The good news is that business leaders are insisting more and more on leading innovation with research, because they recognize that patient safety and patient care are directly tied to business value.

5: There are fluffy bunnies.

Bob Schwartz from GE Healthcare said it well when he framed the two poles in design as “fluffy bunnies versus show me the money.” The “bunnies” represent highly conceptual, strategic design work that doesn’t stand a chance unless designers are willing to embrace the necessary business principles that will ensure their concepts reach patients and clinicians. Designers tend to be more motivated by generative, qualitative research, but interest from business leadership will be limited until that research is validated by quantitative numbers.

6: Technology is being leveraged in super-interesting ways in the name of generative and evaluative research.

Dr. Teodor Grantcharov, a professor of surgery at the University of Toronto, told a rapt audience about the “patient safety black box” he has deployed in an OR at St. Michael’s Hospital in Toronto to track adverse surgical events and analyze potential causes.

The black box records nearly everything in the OR, including video of the surgical procedure, clinician conversations, room temperature, and decibel levels. Dr Grantcharov provided some intriguing insights about this high-risk environment. For example, an OR door is likely to open every two minutes, and human failure accounts for 69% of adverse events. One data point that perhaps works against design researchers gaining more access to the OR is that having eight people in the OR (rather than four people) is correlated with twice the likelihood of adverse events.

… having eight people in the OR (rather than four people) is correlated with twice the likelihood of adverse events.

In another presentation, Charles Mauro of Mauro Usability Science shared how his research consultancy is leveraging haptic sensors and tracking to optimize medical device human factors. He demonstrated how wearable sensors track participant usage of injection devices; how eye tracking combined with EEG (electroencephalography) provides more accurate user feedback on IFU’s (instructions for use); and how micro-facial expression technology (Affectiva) can be used to assess the emotional responses of subjects who are self-injecting medication. On a more basic level, he described how placing a simple 3D tracker inside medical packaging can be an effective indicator of how frustrated people get while trying to open it.

Despite the challenges of developing distinct hardware and software to run this technology, Mauro sees significant opportunity in being able to define true human factors capabilities for specific patient populations.

And Aiden Petrie from Ximedica sees voice recognition technology (aka Alexa) as an important step in breaking down barriers in healthcare through natural language device interfaces that promote patient empathy.

7: AR and VR technology are entering the medical design space.

Pavitra Krishnamani from the DICE group within Jefferson Hospital demonstrated how low-cost Samsung Gear headsets are being leveraged to assist both patients (pain management, rehab, and psychiatry) and clinicians (CPR and emergency care training). She stressed the importance of involving clinicians throughout the process, underlining the need for research in this space to ensure that VR technology is safe and useful for patients.

Bobby Garfield and Alex Dupont have to be complimented for their informative step-by-step overview of how their team at Radius Design is experimenting with AR to evaluate medical device concepts. The gave a live demo using a combination of the Microsoft HoloLens headset, Unity software, and MicroSoft VisualStudio to place physical mockups in a simulated, contextual AR environment.

In their demo, the headset wearer was able to view and interact with the physical mockup of a pole-mounted medical device in the simulated AR environment of a hospital room and bed. This combination of a physical mockup and AR environment simulation allowed the team to create a contextual evaluation that was low cost, travel friendly, and quick! They also discussed how this low-cost approach can be leveraged early in the development process to add value to rapid prototype evaluation.

Lynde Kintner Lutzow is a remarkable industrial designer-turned-medical student, now at Tufts University School of Medicine, who gave a captivating review of just a few of the opportunities for design improvements that she has identified during her experiences in med school.

While there has been immense progress, her training continues to uncover significant opportunities for improving the design of medical devices. Lynde’s hit list included products that are frustrating to use for both clinicians (CT scan outputs, OR lighting, computer workstation carts) and patients (spirometers, nasal feeding tubes, toilet sample “hats”).

Our last takeaway? There’s a long way to go.

We’re a good few years into an impressive industry-wide effort to focus on safety and efficacy through usability in medical product design. We’re well past infancy, but there is still plenty of work to be done.

As Chris Rockwell of Lextant Design, said, “Two things kill the [user] experience…ambiguity and unpredictability,” so let’s keep collaborating to address the challenge of improving the simplicity and clarity of medical devices and healthcare systems!

To Mathieu, design is not just about fixing complicated problems — it's about evoking emotion. And he believes emotional appeal can be rationally and analytically designed. This is the foundation of everything he does at Bresslergroup.

Conall delights in finding unexpected ways to improve people’s day-to-day lives and considers research to be the means to this end. He first realized the potential of design to improve lives and drive innovation when he went off-script with a K’nex set at age ten and, after much trial and error, constructed a repeating rubber-band launcher.